Intuitive Surgical Careers
Sr Business Systems and Process Analyst
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183327
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
This role ensures that all PLM/Document Control projects are implemented in accordance with Intuitive Surgical project management and Document Control standards and meet Regulatory and Compliance standards. The position is responsible for assessing projects’ impact(s) to Document Control processes and other Intuitive Surgical business processes that are supported by or affected by the PLM system. The individual must also work effectively with all areas impacted by the projects - including Operational and Functional business process owners, business end users. This position reports directly to the Senior Manager, Document Control.
Roles & Responsibilities:
- Lead improvement activities for the PLM system (Agile) and training of the system to both Document Control personnel and ISI employees
- Assess impact of proposed changes to the Agile PLM System on the Agile system as well as on Document Control business processes
- Represent Document Control during requirements definition phase of projects
- Participate in planning sessions for approved projects to develop project scope, goals, and deliverables with stakeholders
- Communicate clear expectations to team members and other stakeholders, and continually manage those expectations throughout the life of the project.
- Lead/Participate on multiple project teams. Work with business owners to ensure the team understands users’ business activities and that the acceptance criteria are defined. Lead daily stand-ups, resolve conflict, remove impediments and blocks, and escalate as required
- Lead/participate in triage meetings to manage intake and prioritize work items for the project teams
- Develop complete test scripts related to PLM and Document Control projects. Manage user testing execution phases and resources
- Work with Computer System Validation (CSV) groups in Regulatory and IT to ensure project compliance with regulatory and ISI CSV policies and procedures
- Identify and resolve project issues and manage project dependencies within the Document Control environment to keep the critical path on track. Formulate contingency plans as appropriate to reduce or mitigate project and business risks
- Assess the impact of projects on released procedures. Coordinate and ensure all required documentation are updated and released at the time of project implementation
- Manage/control incidents and service requests associated with projects
- Participate in project post mortems and create a recommendations report in order to document the successes and challenges that were experienced over the life of the project.
- Evaluate, assess, restructure, and maintain the PLM System training program. Ensure that the program is holistic, complete, and effective and that training is efficient. Develop a plan to ensure that training program is always current and complete
- Identify and incorporate orphan processes. Work with business owners to understand orphan processes, develop material for orphan processes, and deliver training to Document Control personnel and users personnel
- Develop and lead Agile Training Forum. Provide world class internal customer services by engaging the PLM community in on-going forums that are well-organized, have clear rules of engagement, and that create a positive and proactive environment
- Become embedded in the process – spend a portion of time processing ECOs and responding to internal customer issues
Skills, Experience, Education, & Training:
• Four year college degree, preferred.• Knowledge of Microsoft Office products (MS Word, MS Excel, MS Visio),• Experience with process development and management in a Regulatory/Quality organization in a medical device company (preferably ISI)• Familiarity with Quality System Regulations and ISO requirements• Strong knowledge of Change Control principles for Document Control and IT systems• Ideally, well-developed relationships with key personnel in ISI (IT, Engineering, Document Control, Manufacturing)• Strong attention to detail.• Planning and organizing adaptability; ability to react to project adjustments & alterations promptly and efficiently• Ability to work with 5+ person cross-functional project teams• Experience at working both independently and in a team-oriented, collaborative environment is essential.• Ability to work in a high-stress, ever changing environment• Strong critical and analytical thinking and problem-solving skills• Persuasive, encouraging, and motivating management style• Strong interpersonal skills• Excellent written and oral communication skills• Self-starter, able to work without supervision
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.